Therapeutic manufacturing
GMP CDMO Services for
Phase 3 | PPQ | Commercial Supply
Eurogentec has established experience supporting Phase 3 and PPQ programs across GMP plasmid DNA, recombinant proteins, and IVT-based mRNA manufacturing.
Established GMP manufacturing
for late-stage programs
Three GMP modalities
for late-stage manufacturing
From microbial expression or in vitro transcription, our GMP manufacturing platforms are designed
to deliver consistent, compliant, and scalable drug-substance production for Phase 3, PPQ campaign
and commercial phase.
Combined with experienced project teams, our established GMP Quality Management System
help shorten the path from process development to validated GMP manufacturing.
GMP plasmid DNA
Our GMP plasmid DNA manufacturing uses microbial production systems to deliver plasmid DNA up to kg-scale for advanced therapies.
We produce plasmids that can serve either as starting materials for example, in mRNA, AAV (adeno-associated virus) or lentiviral vector manufacturing or as active pharmaceutical ingredients (API) when the plasmid itself is the therapeutic component.
Each batch is manufactured under GMP conditions, with complete traceability, release testing, and documentation suitable for Phase 3 and commercial requirements.
GMP mRNA
Eurogentec offers GMP in vitro transcription (IVT) mRNA manufacturing, supporting development from early-stage research to Phase 3 and commercial stage.
Our process covers template preparation, enzyme-based IVT synthesis, and scalable purification , ensuring consistent, GMP-grade drug-substance mRNA.
With almost a decade of mRNA process development expertise, Eurogentec provides flexible production capacities from microgram to 50 g.
Final fill and finish operations are managed by your selected partner or KEGT's partners, ensuring seamless project handover from drug substance to drug product.
GMP recombinant protein
We provide GMP manufacturing of recombinant proteins using microbial expression systems such as E. coli and P. pastoris (K. phaffii).
Our services cover the clone selection, fermentation and purification to deliver drug-substance-ready proteins under fully documented GMP processes.
In addition to standard recombinant proteins, Eurogentec also manufactures protein conjugates and VHH antibody fragments, expanding the range of microbial-based products we can support.
These capabilities are tailored for Phase 3 programs and PPQ readiness, including scale-up qualification and supply chain control.
Late-stage manufacturing experience
Our Quality Management System (QMS) supports projects from early development to
commercialization. Working with biotech and pharmaceutical companies in both human and
veterinary health, Eurogentec has built experience across all stages of process validation,
contributing to a robust GMP manufacturing framework.
Quality agreement
A robust Quality Agreement is a core part of our offering. It sets out roles and responsibilities between sponsor and CDMO regarding all quality topics including change-control pathways, deviation and CAPA (corrective and preventive action) procedures, sub-contractor oversight and audit rights.
Analytical lifecycle & data integrity
Our analytical services support drug substance release, in process testing, stability testing and comparability studies. Methods are developed and validated in line with ICH Q14 and ICH Q2(R2) guidelines, with continued performance monitoring throughout the product lifecycle. Data integrity is maintained through validated systems and controlled data management processes, ensuring traceability and reliability of analytical results.
Capacity, timeline & supply chain readiness
We offer transparent manufacturing timelines for Phase 3 and PPQ projects.
For mRNA, single-use equipment supports agile scale-up, while microbial processes rely on proven, controlled production systems.
We manage critical suppliers and maintain documented supply-chain risk mitigation, allowing you to plan procurement, budgeting, and regulatory filings with confidence.
Long-standing manufacturing experience ensures consistent, on-time delivery for every GMP batch.
